Stage IV Skin Melanoma Clinical Trial
Official title:
Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
PRIMARY OBJECTIVES:
I. Evaluate the immune response of each immunization regimen to determine an optimal regimen
in terms of immune response to recommend for phase II testing.
SECONDARY OBJECTIVES:
I. Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
I. Describe the immunological efficacy of the vaccine preparations as measured by the
frequency and interferon (IFN) gamma production of peptide-specific cytotoxic T lymphocytes
(CTL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive MART-1 antigen and TLR4 antagonist GLA-SE intramuscularly (IM) on day
1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up
to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, stage II patients are followed up at 10 weeks and then
at 6, 12, 18, and 24 months and stage III-IV patients are followed up at 3, 6, 9, 12, 15, 18,
21, and 24 months.
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